Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because in Fig. 6, reference numeral 203 is cut off at the top of the figure. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 4, 7 are objected to because of the following informalities:
claim 4 recites “the proximal portion of the sealing elment” in line 6. While the claim is clear as the sealing element necessarily has a proximal portion, it appears as though the claim may be intended to depend from claim 3 which recites “the sealing elemnt comprises a distal portion and a proximal portion”. Alternatively, the examiner suggests amending the claim ot recite “a proximal portion of the sealing element.”
Claim 7 recites “the distal portion of the sealing element” in line 2. While the claim is clear as the sealing element necessarily has a proximal portion, it appears as though the claim may be intended to depend from claim 3 which recites “the sealing elemnt comprises a distal portion and a proximal portion”. Alternatively, the examiner suggests amending the claim ot recite “a distal portion of the sealing element.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 11, 13, 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “a polymeric material” in line 2. It is not clear if this refers to the same polymeric material introduced in claim 1 or a different polymeric material.
Claim 11 recites the limitation "the cavity" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites “another retaining ring” in line 2, and “the retaining ring” in line 3. “A retaining ring” is introduced in claim 12, however claim 13 depends from claim 8. Therefore, there is no antecedent basis for the limitations recited in claim 13.
Claim 14 inherits the deficiencies of claim 13.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beebe (US 6,676,642) in view of Fischer (US 4,986,820).
Regarding claim 1, Beebe discloses a stopper assembly configured to be disposed in a barrel of an injection device containing a medicinal fluid (fig. 4), the stopper assembly comprising a stopper 20 having a laterally outermost surface configured to be directly engaged with an inner surface of the barrel (fig. 4 annotated below), and a sealing element 8 coupled to and axially distal relative to the stopper in the barrel (fig. 4), the sealing element having a laterally outermost surface configured to be directly engaged with the inner surface of the barrel (fig. 4 annotated below) and to sealingly isolate the stopper from the medicinal fluid in the barrel (fig. 4; col. 3, lines 7-11: problem to be solved is the piston deforming and allowing fluid to contact the portion proximal to the piston and therefore in the disclosed configuration, the piston isolates the stopper from the fluid).
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Claim 1 further calls for the sealing element to be made of a rigid or semi-rigid polymeric material that is not axially compressible. Fischer teaches a stopper assembly wherein the sealing element is formed from a relatively noncompressible material such as polypropylene or polyethylene that allows preloading of the syringe with a liquid medicament without the sealing means leaking or reacting with the medicament (col. 4, lines 19-33). It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing element of Beebe to be formed from a material such a polypropylene or polyethylene as taught by Fischer to provide a material that has an effective sealing without leaking or reacting with the medication. This material is semi-rigid and not axially compressible.
Regarding claim 2, Fischer teaches that the polymeric material is chemically inert to the medicinal fluid (col. 4, lines 19-33; col. 6, lines 23-31) as discussed above with regard to claim 1.
Regarding claim 3, Beebe discloses that the sealing element has a distal portion and a proximal portion, the distal portion having a maximum lateral dimension greater than a maximum lateral dimension of the proximal portion (see fig. 4 annotated below).
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Regarding claim 4, Beebe discloses that the stopper has a distal surface and a proximal surface, the stopper comprises a cavity extending into the stopper from the distal surface, and the proximal portion of the sealing element is disposed in the cavity of the stopper (see fig. 4 annotated below).
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Regarding claim 5, Beebe discloses that the cavity comprises a laterally-extending groove and the proximal potion of the sealing element comprises a laterally-extending projection, the projection received in and engaged with the groove to couple the stopper to the sealing element (see fig. 4 annotated below).
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Regarding claim 7, Beebe discloses that the distal portion of the sealing element is disc-shaped (fig. 4).
Regarding claim 8, Beebe discloses an injection device comprising a barrel 4 extending axially between a distal end (fig. 4 right side of page) and a proximal end (fig. 4 left side of page), the barrel configured to contain a medicinal fluid 6 (fig. 4), a plunger rod 18 having a distal end and a proximal end, the distal end of the plunger rod disposed in the barrel (fig. 4), and a stopper assembly disposed in the barrel (fig. 4), the stopper assembly comprising a stopper 20 having a laterally outermost surface configured to be directly engaged with an inner surface of the barrel (fig. 4 annotated below), and a sealing element 8 coupled to and axially distal relative to the stopper in the barrel (fig. 4), the sealing element having a laterally outermost surface configured to be directly engaged with the inner surface of the barrel (fig. 4 annotated below) and to sealingly isolate the stopper from the medicinal fluid in the barrel (fig. 4; col. 3, lines 7-11: problem to be solved is the piston deforming and allowing fluid to contact the portion proximal to the piston and therefore in the disclosed configuration, the piston isolates the stopper from the fluid).
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Claim 8 further calls for the sealing element to be made of a rigid or semi-rigid polymeric material that is not axially compressible. Fischer teaches a stopper assembly wherein the sealing element is formed from a relatively noncompressible material such as polypropylene or polyethylene that allows preloading of the syringe with a liquid medicament without the sealing means leaking or reacting with the medicament (col. 4, lines 19-33). It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing element of Beebe to be formed form (from?) a material such a polypropylene or polyethylene as taught by Fischer to provide a material that has an effective sealing without leaking or reacting with the medication. This material is semi-rigid and not axially compressible.
Regarding claim 9, Beebe discloses that the stopper is sealingly enclosed between the sealing element and the plunger rod (fig. 4).
Claim(s) 6, 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beebe in view of Fischer as applied to claims 1 or 8 above, and further in view of Sudo et al (US 6,090,081).
Claim 6 differs from the teachings above in calling for the laterally outermost surface of the sealing element to have a surface roughness in a range from about 0.012 µm to 0.10 µm. Sudo teaches a syringe having a sealing element wherein the sealing element has an outermost surface having a surface roughness of 0.05 µm which is within the claimed range, the surface roughness providing a high sealing property and slidable property (col. 5, lines 18-27) thereby ensuring that the syringe does not leak during storage and also does require excessive force to deliver the fluid from the syringe. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing element of Beebe to have a surface roughness of 0.05 µm as taught by Sudo to provide good sealing properties and good sliding properties.
Claim 10 calls for the maximum lateral dimension of the inner surface of the barrel to be less than the maximum lateral dimension of the distal portion of the sealing element such that the distal portion of the sealing element is laterally compressed within the barrel in a storage position. Sudo teaches a syringe wherein the internal diameter of the syringe barrel is smaller than the external diameter of the sealing element such that the sealing element forms a reliable seal with the barrel to prevent leakage (col. 9, lines 18-25; fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel and sealing element of Beebe such that the internal diameter of the barrel is less than the external diameter of the sealing element such that the sealing element is laterally compressed as taught by Sudo to form a reliable seal within the barrel.
Regarding claim 11, Sudo teaches that the maximum lateral dimension of the stopper is greater than the maximum lateral dimension of the inner surface of the barrel as discussed with regard to claim 10 above. Such a configuration would transmit a compressive force from the barrel to the sealing element and the distal portion of the stopper such that the proximal portion of the sealing element is compressed within the cavity.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beebe in view of Fischer as applied to claim 8 above, and further in view of Roland (FR 2 670 387 A1).
Regarding claim 12, Beebe discloses that the stopper assembly is configured to be axially movable from a storage position (initial position) to a use position (delivery movement) within the barrel. Claim 12 differs from the teachings above in calling for the barrel to comprise a retaining ring proximate to the proximal end thereof, and the stopper assembly is located axially distal relative to the retaining ring in the storage position. Roland teaches a syringe barrel having a retaining ring 15 proximate to the proximal end (fig. 1), the stopper assembly 14 located distal to the retaining ring (fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel of Beebe to include a retaining ring as taught by Roland to prevent the stopper assembly from being removed from the syringe barrel.
Allowable Subject Matter
Claims 13, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 13 is rejected under 112(b) as discussed above, however, the claim contains subject matter that was not suggested by the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783